I’m pleased to share the latest issue of Vaccines for the Future, which features news about the launch of three clinical trials for vaccines against diarrheal diseases, as well as the announcement of several new partnerships with PATH projects related to vaccines against Shigella, enterotoxigenic Escherichia coli, pneumococcus, rotavirus, and influenza. In addition, we report on highlights from a variety of recent meetings in which PATH was involved, including one focused on barriers to effective mucosal immunization of infants and another reviewing protein vaccine development for Streptococcus pneumoniae. This edition also spotlights an exhibition featuring PATH-supported pneumococcal disease surveillance work in Pakistan and the first India Vaccinology Course to be hosted at Christian Medical College, Vellore, which will feature several PATH staff members as lecturers.

Finally, we include links to a few new items on our Vaccine Resource Library website, our regular updates on upcoming conferences and events, and current employment opportunities at PATH. We hope you continue to find our updates useful and informative, and we always welcome your feedback.

Sincerely,
John W. Boslego, MD
Director,Vaccine Development Global Program
PATH

PATH supported the March launch of a Phase 2/2b trial of an oral enterotoxigenic Escherichia coli (ETEC) vaccine by TD Vaccines, a company based in Denmark. The trial, which is taking place in Baltimore, Maryland, at Johns Hopkins University, will test the safety and immunogenicity of ACE527, a live attenuated whole cell vaccine comprising three ETEC strains. In addition to testing the vaccine in 72 healthy adults, the trial also includes a “challenge” component with 56 participants to measure the extent of protection provided by the candidate. The trial is expected to finish by December with complete results available in early 2011. In addition, PATH co-funded the May launch of a Phase 1 trial of a novel oral, inactivated whole cell ETEC vaccine with the University of Gothenburg in Sweden. This study, which is taking place at the University, will determine whether the new vaccine is safe, if it induces an immune response, and if the immune response is stronger than that of a previously tested version of this vaccine. Researchers are administering two vaccine doses to each of the 60 healthy adults in the study, using one of two dose levels of vaccine. The trial is expected to conclude by November with results available in early 2011.

In related news, PATH’s enteric vaccine project recently signed several new agreements. PATH is partnering with the International Vaccine Initiative in Seoul, Korea, on the development of a prototype vaccine against Shigella based on a novel antigen, Pan-Shigella Surface Protein 1. PATH is also supporting Oklahoma State University to conduct research on a vaccine against Shigella comprising conserved proteins as a novel means of inducing broad immune coverage. Finally, PATH is collaborating (PDF) with the US Naval Medical Research Center in Silver Spring, Maryland, to conduct laboratory toxicology testing of a new adhesin-based vaccine candidate against ETEC.

Effective oral immunization of infants and young children in the developing world against enteric pathogens has long been a challenge for vaccine developers. PATH recently co-funded a two-day workshop at Old Herborn University in Germany that brought together a panel of experts to review what is currently known in this area and to map a strategy forward for mucosal immunization to be used more effectively among children in developing countries. At a public session on June 24, several mucosal immunization specialists presented background information on enteric illness in developing-world infants and the current challenges faced in developing oral vaccines for this population. On June 25, the workshop continued with a closed-door, in-depth discussion among the experts to address specific research questions related to this topic in order to identify what research and advances are needed to fill this gap. Several attendees will write an article on the results of this discussion for publication in a peer-reviewed journal.

The global health community is celebrating a World Health Assembly resolution passed in May to prioritize the prevention and treatment of childhood pneumonia—the number one killer of children less than five years of age worldwide. The commitment is an important step toward building momentum in the global fight against this deadly disease. On the heels of this announcement, PATH’s pneumococcal vaccine project and the US National Institute of Allergy and Infectious Diseases co-sponsored an invitational meeting in Washington, DC, from June 10 to 11 that brought experts together to review protein vaccine development for Streptococcus pneumoniae—the most common cause of invasive pneumonia. Participants identified needs and challenges for research and development, and agreed on the importance of defining a target product profile and a clear regulatory pathway to enable eventual protein vaccine introduction. Such vaccines, if successful, could provide broad, affordable protection across virtually all pneumococcal serotypes, making them promising options for low-resource countries.

As part of the continuous pursuit of better, more affordable vaccines against S. pneumoniae, PATH is also supporting the development of new pneumococcal conjugate vaccines (PCVs) tailored to meet needs in developing countries. To speed time to market for these PCVs, PATH and its vaccine development partners in China and India are moving forward with efforts to rapidly advance low-cost PCV candidates targeted solely to serotypes prevalent in the developing world. To support this objective, PATH recently formed a new preclinical research partnership with British biotechnology company Glythera Limited to evaluate an alternative conjugation method for the production of PCVs using its proprietary conjugation technology—PermaLink. This new agreement is complementary to PATH’s work with the US Food and Drug Administration’s Center for Biologic Research and Evaluation on a research effort to optimize a conjugation process for PCVs.

The Smithsonian’s Cooper-Hewitt, National Design Museum in New York City is hosting an exhibition until January 9, 2011 that showcases Interactive Alerts—a disease surveillance device developed under the leadership of Interactive Research & Development, Johns Hopkins University, and the Massachusetts Institute of Technology. With support from PATH and other partners, the technology is currently being utilized in field studies in Karachi, Pakistan, to monitor invasive pneumococcal disease. The device is mobile phone-based and uses Radio Frequency Identification technology, making it a relatively low-cost option for monitoring immunizations and tracking and referring patients. The exhibition, entitled “National Design Triennial: Why Design Now?,” will include a display about the Pakistan project as one of 125 international initiatives featured for their work promoting solutions in environmental stewardship, social equity, accessibility, and creative capital within a series of general themes, including health.

Murdoch Childrens Research Institute (MCRI) in Melbourne, Australia, recently announced (PDF) the launch of a clinical trial to test a new vaccine candidate, RV3, to protect newborn infants against rotavirus. Current commercial rotavirus vaccines are given to infants beginning at six to eight weeks of age, which may leave newborns at risk of early infection and can result in delay of vaccine administration, particularly in countries with limited health care access. Infants aged six to eight weeks are being recruited in Melbourne for the trial of RV3, which will be given in a single oral dose. If successful, MCRI will further test it in infants in two larger international trials in Indonesia and New Zealand starting in 2011. The vaccine was developed with financial support from PATH, Australia’s National Health & Medical Research Council, the New Zealand Health Research Council, the World Health Organization, and in collaboration with Indonesian vaccine manufacturer BioFarma.

PATH recently signed an agreement with Christian Medical College (CMC), Vellore in India to establish the site as a reference laboratory to standardize the immunological assays of the bovine-human reassortant rotavirus vaccine (BRV) by providing common reagents, uniform protocols, and training to the clinical immunology laboratories of each manufacturer actively developing a BRV candidate. PATH’s rotavirus vaccine development project supports these manufacturers through a unique “shared technology platform” to provide access to technologies, training, methodologies, and materials. As part of this effort, PATH is establishing the reference laboratory to allow for the comparison of data from clinical trials conducted in different populations and locations. In addition to serving in this role, CMC, Vellore will also provide technical support on the immunological assays to the BRV manufacturers.

One aspect of the shared technology platform is PATH’s Annual Manufacturers Meeting for its partners that are actively developing BRV candidates. The fourth meeting of this group was held in Kuala Lumpur, Malaysia, on June 16 to 17 and brought together more than 40 participants from the manufacturers and several supporting organizations to share ideas and information related to development of the BRV. Presentations and discussions focused on process development, quality control, formulation and packaging, clinical study design, epidemiology and serotypes, and laboratory and regulatory issues.

PATH recently signed an agreement with the Infectious Disease Research Institute in Seattle, Washington, to advance research on adjuvants—additives that can enhance a vaccine’s immune response—for influenza vaccine candidates. Under the agreement, researchers will determine leading emulsion formulations for further characterization with an emphasis on co-development with different influenza vaccine candidates receiving support from PATH’s influenza vaccine project. By improving immune responses, adjuvants can reduce the amount of antigen needed to make a vaccine effective, making them a promising strategy for conserving doses and enabling global access to vaccine in an influenza pandemic.

On September 20 to 30, CMC, Vellore will host the first India Vaccinology Course (PDF) to provide a comprehensive overview of the field and strengthen capacity within India. The course will cover many aspects of vaccinology, including basic immunology, the vaccine development process, licensure and regulatory requirements, vaccine clinical trials and introduction, and the translation of research into policy, all of which will be presented in the context of India’s growing vaccine industry. This is the first time the course is being offered and organized in India, and it will be similar to those offered regularly at the International Vaccine Initiative in Seoul, Korea, and Fondation Mérieux in Lyon, France. The course is being supported by the Department of Biotechnology in India, the Research Council of Norway, the Indian Academy of Paediatrics, the Child Health Foundation of South Asia, and the Society for Applied Studies. Several PATH staff members who are experts in the field of vaccine development will serve as lecturers.

The 9th International Rotavirus Symposium, Johannesburg, South Africa, August 2 to 3. This meeting will feature presentations from global experts on the latest progress in rotavirus vaccine research, introduction, and disease prevention. Presented by PATH, the Sabin Vaccine Institute, the US Centers for Disease Control and Prevention, and the University of the Witwatersrand, the symposium will mark the first major gathering of stakeholders since the January release of clinical data demonstrating rotavirus vaccines’ significant reduction of severe disease in impoverished settings of Africa and Asia. Several PATH staff members and partners will present at the meeting.

The Immunotherapeutics and Vaccine Summit, Cambridge, Massachusetts, August 17 to 19. Leaders in the international vaccine community will convene for four meetings focused on the design and development of novel vaccines, vaccine production and manufacturing, adjuvant and delivery systems for novel vaccines, and preclinical and clinical vaccine development challenges. Dr. Mark Alderson, director of PATH’s pneumococcal vaccine project, will deliver a presentation on protein, conjugate, and hybrid strategies for new pneumococcal vaccines.

Options for the Control of Influenza VII, Hong Kong, China, September 3 to 7. This premier influenza conference will bring together experts from around the world to review the latest advancements in influenza prevention, control, and treatment, along with strategies related to seasonal and pandemic planning. PATH will host a booth in the exhibition hall and sponsor a number of travel scholarships for researchers from underserved regions to attend the conference. Dr. Kathleen Neuzil, director of PATH’s influenza vaccine project, will also co-chair a workshop session entitled “Epidemiology, Disease Burden, and Health Economics.”

4th Vaccine and International Society for Vaccines Annual Global Congress, Vienna, Austria, October 3 to 5. This meeting brings together scientists, governmental authorities, and health care workers with dedicated sessions for each group to exchange ideas for accelerating progress in the development of vaccines. Dr. Rick Bright, scientific director of PATH’s influenza vaccine project, will present on the design and development of novel vaccines for the developing world.

Modern Vaccines/Adjuvants Formulation 2010, Cannes, France, October 13 to 15. This conference will offer an international forum for the discussion of all aspects of vaccine formulation, with a focus on pharmaceutical development of vaccines and adjuvants, safety issues with special emphasis on delivery/administration issues, and national and international regulatory guidelines. Dr. Dexiang Chen, senior technical officer for PATH’s technology solutions program, will present on formulations for mucosal delivery of vaccines and microbicides.

48th Annual Meeting of the Infectious Diseases Society of America, Vancouver, Canada, October 21 to 24. This meeting will convene physicians, scientists, and other health care professionals to participate in a program focused on continuing education in pathophysiology, diagnosis, treatment, and prevention of infectious diseases. Dr. Neuzil will deliver the Joseph E. Smadel Lecture on maximizing the global impact of vaccines, with a look at recent successes and an eye toward opportunities for reducing vaccine-preventable diseases in low-resource settings.

PATH’s vaccine development program is working to accelerate the development of innovative, safe, effective, and affordable vaccines against the leading causes of childhood deaths in the developing world, pneumonia (pneumococcal disease) and diarrheal disease (rotavirus, Shigella, and enterotoxigenic Escherichia coli), as well as new influenza vaccines for the global population. PATH is also partnering on vaccine development through its Malaria Vaccine Initiative and the Meningitis Vaccine Project. Additionally, PATH works to ensure the worldwide availability of vaccines through its vaccine access and delivery program. The work of the vaccine development program is currently supported by grants from the Bill & Melinda Gates Foundation, the US Centers for Disease Control and Prevention, and the United Kingdom's Department for International Development. Some projects within the vaccine development program are funded by PATH Vaccine Solutions.

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